argenx Vyvgart sBLA acceptance in seronegative gMG comes with priority review
argenx announced that the FDA has accepted for priority review a sBLA for Vyvgart IV for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG), with a PDUFA target action date of 10 May 2026. The sBLA acceptance and priority review for Vyvgart in seronegative gMG brings argenx a step closer to its aim of having the broadest possible label in this setting. argenx estimates the commercial opportunity for seronegative gMG could add 11K patients on top of the 17K addressable population at launch in the US. € 900 TP and BUY maintained.Argenx N.V. is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. Utilizing its suite of differentiated technologies, Co. is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need.
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